Post-operative wound infection treatments studied
William Obremskey, M.D., MPH
Vanderbilt University Medical Center will be the principal site in the four-year, $3 million clinical trial, along with 11 civilian sites and three military clinical sites involved in the METRC.
The principal investigator is William Obremskey, M.D., MPH, associate professor of Orthopaedics and Rehabilitation. Kristin Archer, Ph.D., assistant professor of Orthopaedics and Rehabilitation, is the project director at VUMC.
Bone fractures are a common battlefield injury and most are treated with internal fixation of plates and screws, but up to 40 percent of fractures develop an infection before the bone is healed.
The study will compare the effects of oral versus intravenous (IV) antibiotics in patients who have an infection following internal fixation.
“We expect there to be no difference in curing patients with oral antibiotics,” Obremskey said.
“Oral antibiotics are an advantage because they are lower cost and there is no risk of line infections or blood clots due to catheters in veins.”
The study seeks to enroll 600 patients who contract an infection within 6 weeks of internal fixation. They will be randomized into two groups: one receiving oral antibiotics and one receiving IV antibiotics.
Assessments will be made at intervals over one year to determine rates of treatment failure, re-hospitalization, infection, non-union of the bone, amputation and patient compliance with antibiotic treatment.
METRC, which was established in 2009, recently received $38.6 million in additional funding from the Peer Reviewed Orthopaedic Research Program (PRORP) of the Department of Defense Congressionally Directed Medical Research Program (CDMRP).
The total funding for METRC is nearly $70 million and will allow the consortium to expand its work in establishing guidelines for the optimal care of wounded military service men and women.
Obremskey said this study will hopefully reduce complications for soldiers with infections and may allow them to return home during convalescence because they will not require IV antibiotics.
“Improved strategy of early postoperative wound infections in fact can decrease long-term morbidity, improve limb function, decrease amputations and improve quality of life in injured soldiers,” he said.
“Treatment regimens can be less risky, less expensive, and consume fewer health care resources.”